Asian Journal of Pharmaceutical Analysis

B. Thangabalan ¹, M. Salomi ¹, N. Sunitha ¹, S. Manohar Babu ¹

Affiliations
1 Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), IN

Abstract

A simple, fast and precise RP-HPLC method was developed for the quantification of Itraconazole in pure and pharmaceutical dosage form. The quantification was carried out using Dionex C18 4.6 X 250mm, 5μm enhanced polar selectivity column and mobile phase comprised of methanol and pH 7.5 potassium dihydrogen phosphate in the ratio of 40:60 and degassed under ultrasonication. The flow rate was 1.5ml/min and the effluent was monitored at 306nm. The retention time of Itraconazole was found to be 5.2 min. The method was validated in terms of linearity, precision, accuracy, specificity, robustness, limit of detection and limit of quantitation in accordance with ICH guidelines. Linearity of Itraconazole was in the range of 200-600 μg/mL. The percentage recoveries of Itraconazole were 99.33% to 99.66% from the capsule formulation. The proposed method is suitable for determination of Itraconazole in pharmaceutical dosage form.

Keywords

Chromatography, Itraconazole, Method Validation.

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N. Sunitha ¹, L. Sindhura ¹, B. Thangabalan ¹, S. Manohar Babu ¹

Affiliations
1 Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), IN

Abstract

A new, rapid, highly sensitive, economical and accurate RP-HPLC method was developed for simultaneous estimation of Cefepime and Tazobactam in injection formulation. The separation was achieved by C18 column (150 × 4.6 mm, 5 μ particle size) with mobile phase consisting of phosphate buffer (pH 2.4, diluted with orthophosphoric acid), methanol and acetonitrile in the ratio of 90:5:5 v/v, using flow rate 1.1 mL/min and eluents monitored at 260 nm. The developed method was validated as per ICH guidelines for specificity, linearity, precision, accuracy, robustness, limit of detection and limit of quantification. The retention times of cefepime and tazobactam were 2.236 and 4.498 min respectively. The linearity was found to be in the range of 250-750 μg/mL and 31.25-93.75 μg/mL for cefepime and tazobactam sodium respectively, had regression coefficients (R2) 0.999. The proposed method was successfully applied for simultaneous estimation of both drugs in injection formulation.

Keywords

RP-HPLC, Cefepime, Tazobactam, Injection, Validation.

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B. Thangabalan ¹, Avinash Koya ¹, G. Chaitanya ¹, N. Sunitha ¹, S. Manohar Babu ¹

Affiliations
1 Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), IN

Abstract

A simple, fast and precise stability indicating RP - HPLC method was developed for the separation and quantification of Acamprosate in pharmaceutical dosage form. The quantification was carried out using Hypersil C18 4.6X150 mm, 5 μm enhanced polar selectivity column and mobile phase comprised of 0.2M Ammonium acetate and acetonitrile in proportion of ratio 40:60 and degassed under ultrasonication. The flow rate was 1mL/min and the effluent was monitored at 220 nm. The retention time of Acamprosate was 4.187min. The method was validated in terms of linearity, precision, accuracy, specificity, limit of detection and limit of quantitation in accordance with ICH guidelines. Linearity of Acamprosate was in the range of 5 - 30 μg/mL. The percentage recoveries of Acamprosate was 99.00% from the tablet formulation. The stability - indicating capability was established by forced degradation experiments. The proposed method is suitable for determination of Acamprosate in pharmaceutical dosage form.

Keywords

Chromatography, Acamprosate, Forced Degradation, Method Development, Method Validation.

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